Study to Compare the Combination of Gliclazide MR and Basal Insulin Versus Premixed Insulin Monotherapy Treatment - Full Text View

Sponsored by:	Servier (Tianjin) Pharmaceutical Co. LTD.
Information provided by:	Servier (Tianjin) Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:	NCT00736515

Purpose

The purpose of this study is to demonstrate if the combination treatment of Gliclazide MR and basal insulin can reduce the dosage of insulin and hypoglycemias compared with pre-mix insulin monotherapy treatment.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: gliclazide MR and lentus	Phase IV

MedlinePlus related topics: Diabetes Hypoglycemia

Drug Information available for: Insulin Gliclazide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 4 Study of Comparison of Combination Therapy of Gliclazide MR and Basal Insulin Versus Pre-Mix Insulin Monotherapy Treatment.

Further study details as provided by Servier (Tianjin) Pharmaceutical Co. LTD.:

Primary Outcome Measures:

insulin dosage and decrease of HbA1c [ Time Frame: After 3 months treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Hypoglycemias [ Time Frame: After 3 months treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	160
Study Start Date:	October 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator The patients will received the combination treatment of 60~120mg Diamcron MR and once daily basal insulin	Drug: gliclazide MR and lentus Combination treatment of once daily gliclazide MR (60-120mg) before breakfast and once daily basal insulin(start with 0.2U/KG/D) before dinner.
2: Active Comparator The patients will receive the treatment of twice daily of pre-mixed insulin for three months.	Drug: gliclazide MR and lentus Combination treatment of once daily gliclazide MR (60-120mg) before breakfast and once daily basal insulin(start with 0.2U/KG/D) before dinner.

Detailed Description:

Inclusion criteria:

The blood glycemia of the patients were uncontrolled after 3 months OADs treatments.
FPG>7.0 mmol/L and 7.5%<HbA1c<10% 3.19kg/m2<BMI<32kg/m2

Main exclusion criteria:

Type 1 diabetes patients
Insufficient of liver and kidney function
The patients who had cardiovascular events half one year before recruited in this trial.

Primary endpoint:

The dosage of insulin
The decrease of FPG and HbA1c

Eligibility

Ages Eligible for Study:	35 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The blood glycemia of the patients were uncontrolled after 3 months OADs treatments.
FPG>7.0 mmol/L and 7.5%<HbA1c<10%
19kg/m2<BMI<32kg/m2

Exclusion Criteria:

Type 1 diabetes patients
Insufficient of liver and kidney function
The patients who had cardiovascular events half one year before recruited in this trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736515

Contacts

Contact: Liu Pei, Master

86-010-65610341 ext 210

pei.liu@cn.netgrs.com

Locations

China
Servier (Tianjin) pharmaceutical Co. LTD.
Beijing, China, 100020

Sponsors and Collaborators

Servier (Tianjin) Pharmaceutical Co. LTD.

Investigators

Principal Investigator:

Jia W ping, PHD

No.6 People's Hospital of Shanghai, China

More Information

Publications:

Janka HU, Plewe G, Riddle MC, Kliebe-Frisch C, Schweitzer MA, Yki-Järvinen H. Comparison of basal insulin added to oral agents versus twice-daily premixed insulin as initial insulin therapy for type 2 diabetes. Diabetes Care. 2005 Feb;28(2):254-9.

Responsible Party:	Servier (Tianjin) Pharmaceutical Co. LTD ( Marketing Department )
Study ID Numbers:	IC4-5702-205-CHN
Study First Received:	August 15, 2008
Last Updated:	September 1, 2008
ClinicalTrials.gov Identifier:	NCT00736515
Health Authority:	China: Ethics Committee

Keywords provided by Servier (Tianjin) Pharmaceutical Co. LTD.:

CODMS

Study placed in the following topic categories:

Metabolic Diseases
Gliclazide
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009